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TriMed Inc. recalls TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The
Recalled November 20, 2019 · FDA recall Z-0366-2020 · TriMed
Hazard
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified. · FDA Class II
Units
583 Bone Plates
Sold at
US Nationwide distribution in the states of MD, UT.
Description
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
Product
TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.
Manufacturer(s)
TriMed Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →